Deal Flow

Flublok, the first recombinant flu vaccine, reshapes the market

Protein Sciences plans to ramp up to 30 million doses in the next five years

PHOTO BY Scott Kingsley

Dr. Manon Cox is president and CEO of Protein Sciences Corporation in Meriden, Conn. Her company has developed an FDA approved influenza vaccine manufacturing process using a proprietary protein expression technology that can produce high quality recombinant proteins, quickly, reliably and at a low cost.

By Richard Asinof
Posted 8/10/15
The new recombinant flu vaccine, Flubok, promises to be a driving force in changing the market for how flu vaccines – and all other vaccines – are manufactured. The Flublok vaccine is touted as being purer, safer and more effective. The story of Protein Sciences’ success is a wake-up call for the state of Rhode Island to identify and invest in the opportunities presented by the emerging biomedical industry sector.
What are the market forces that will make CVS Health reconsider and offer Flublok to its customers? If the owners of the Red Sox are willing to pay for a tour of the Durham baseball stadium, is Rhode Island’s economic development team willing to take a drive to Connecticut to tour the Protein Sciences facilities? Or, for that matter, to take a tour of the EpiVax facilities in Providence? What are the infrastructure investments needed to attract new biomanufacturing plants to locate in Rhode Island, similar to Alexion Pharmaceuticals and Amgen?
The expanding role that Brown University is playing in reshaping Rhode Island’s economic map as part of its strategic direction to move toward emphasizing its role as a research university is still vastly underappreciated. The third class of the Executive Masters in Healthcare began last week; the first-in-the-nation dual degree program in primary care and population health was also launched last week at the Warren Alpert Medical School, welcoming its first 16 students. There are more innovative educational programs in the works. The opportunities for further collaboration across disciplines and institutions – with the University of Rhode Island, with Johnson and Wales, with RISD, with Rhode Island College, and with Roger Williams University – is perhaps where the state should be making investments.

MERIDEN, Conn. – With another flu season fast approaching, and with it, concerns about the potential effectiveness of flu vaccines to combat two strains of flu virus expected to be in circulation, it seemed like a good time to do a story on Protein Sciences and its innovative, FDA-approved flu vaccine, Flublok.

The success of Protein Sciences also offers a glimpse into potential opportunities and return on investments offered by investments in Rhode Island’s emerging biomedical industry sector.

Flublok, which Protein Sciences calls the world’s first licensed influenza vaccine that is manufactured using recombinant DNA technology, is approved for use for anyone over 18 years of age.

It is marketed as being a highly pure product: it contains no egg protein, gelatin, thimersal [a mercury derivative], latex, gluten, antibiotics, formaldehyde or influenza virus, according to Protein Sciences.

And, it's highly effective, according to Protein Sciences. A recent clinical study of Flubok involving approximately 9,000 adults 50 years or older showed that Flublok recipients were 31 percent less likely to develop laboratory-confirmed influenza than people who received a traditional, egg-based vaccine.

Unlike the traditional 70-year-old egg-based technology that is used to produce most flu vaccines, Protein Sciences uses recombinant technology to produce large quantities of the protein that is the active ingredient in flu vaccines.

In July, the FDA approved the composition of the Flublok influenza vaccine for the upcoming 2015/2016 flu season, which includes protections against the two flu strains that are predicted to be in circulation. And, unlike the slower egg-based production process, Protein Sciences expects to deliver Flublok to distributors and retailers in mid-August, facilitating early availability of the shot.

In addition, the FDA has shown its confidence in Flublok and Protein Sciences by granting exclusivity to Flublok until January 2025, ensuring that no other product similar to Flublok can be approved by the FDA before that date.

Protein Sciences is also collaborating with EpiVax, the Rhode Island company led by Dr. Annie S. De Groot, to produce a tweaked recombinant vaccine for the H7N9 flu, working with the federal Biomedical Advanced Research and Development Authority, or BARDA, to get approval to move into production. [See link to ConvergenceRI story below.]

The privately held company also recently received FDA approval to manufacture its Flublok vaccine commercially at its Pearl River, N.Y. facility, at an 83,000-square-foot plant that once served as Pfizer manufacturing facility for a children’s vaccine. With the addition of the Pearl River facility, Protein Sciences can increase its production capacity.

“We have made some major progress in expanding our production of Flubok, with our facility in Pearl River, right across from the Tappan Zee Bridge,” Dr. Manon Cox, the president and CEO of Protein Sciences, told ConvergenceRI. “We are licensed to bring 1.2 million doses of Flublok to market this year. We are planning to ramp up production to 30 million doses in five years, in combination with our Japanese partners.”

Here then is an interview by ConvergenceRI with Manon Cox, discussing the potential of Flublok to emerge as a major competitor to the traditional flu vaccine.

ConvergenceRI: How did the most recent meeting go with BARDA about the investment in manufacturing the H7N9 flu vaccine? Is there a timeline to go into production?
COX:
We were sent back home to do some more homework.

ConvergenceRI: Has the cost increases in eggs, driven by the wave of avian flu here in the United States, influenced the cost equation for the production of the traditional flu vaccine?
COX:
 Most flu vaccines are not made in the United States, there is very limited production here.

Sanofi, for instance, has a very large contract, something like $50 million a year for a year-round egg supply. They source their eggs from farms that are highly protected. The [avian flu] will have no real impact on the cost of producing flu vaccines.

ConvergenceRI: Do you plan to expand the production capacity for Flublok?
COX:
We made some major progress with our facility in Pearl River, New York, right across from the Tappan Zee Bridge, becoming commercially licensed to manufacture Flublok. We expect to bring 1.2 million doses of Flublok to market this year.

We are planning to ramp up production, to manufacture 30 million doses in five years, in combination with our Japan partners.

We have data from a controlled clinical study on people older than 50 years of age showing that people who were given Flublok were 31 percent less likely to the flu compared to the egg-based vaccine.

That should open the door for Flublok at hospitals.

The cost of Flublok to consumers is zero; it is a preventive measure, if you have health insurance, it’s covered under the Affordable Care Act.

ConvergenceRI: How has the relative success of Flublok positioned Protein Sciences in the marketplace. How much are you anticipating ramping up to meet demand? Will that mean hiring additional employees and expanding production facilities?
COX:
We can ramp up production to about 5 million doses a year. It will certainly create jobs and more work opportunities. After that, we are likely to source our drug substance from Japan.

It is cheaper to outsource production to Japan.

ConvergenceRI: Do you have ongoing collaborations in place with the medical school at Yale, or UConn, or Quinnipiac?
COX:
The conversations are not happening all. There is some connection to the medical school at Quinnipiac; our chief medical officer may be doing some lecturing there.

I think that those academics at UConn and Yale don’t seek out collaborations with our industry.

The University of Rochester and Mt. Sinai are academic institutions outside the state [of Connecticut] that are heavily involved in influenza research.

We are also upping our public relations activities, working with a former news anchor on Connecticut television. We started an active campaign on social media, as well as a radio campaign on I Heart Radio.

ConvergenceRI: What’s your messaging?
COX:
As you commercialize a vaccine, it’s important that people know about that product and where they can get it.

With Flublok, it’s for people 18 years and older. It’s an antigen vaccine, with a good immune response. Translated, Flublok can achieve better performance [against the flu than egg-based vaccines.] It doesn’t matter if you’re 18 or 73, or anywhere in between.

ConvergenceRI: How does the pricing work? Isn’t Flublok a bit more expensive?
COX:
What we found out with our market research is that pharmacies are interested in getting traffic into the store. Walgreens and CVS and RiteAid, they are very much stuck to using the cheaper vaccines. The reason – flu vaccines are a way to get people into their stores, not necessarily to keep them healthy. It’s Machiavellian, it’s about the drive to get people into their stores.

Flublok is carried in Target and Walmart, but not in the big pharmacy chains. It’s also available in a lot of family-owned pharmacies. Doctors can carry it, too.

ConvergenceRI: How long do you think before the market changes and adapts and adopts Flublok as a better, more effective vaccine?
COX:
This came out recently from [some folks] at Novartis, who said that our vaccine is the best choice. They said that they were scared to death [about our product]. The pure vaccine has advantages over the egg-based technology, which is 70 years old; we’re not driving around in old cars from 70 years ago.

The market is going to switch to recombinant vaccines; it will take five to 10 years, if we can get this commercialization right. We can change over the entire market. The FDA has given us a 12-year exclusivity; they are not going to review any other products that are produced in a similar business.

ConvergenceRI: Is there anything that I should have asked that I didn’t ask? You have the last word.
COX:
If people in Rhode Island want to get Flublok, they can go to Target, or Walmart, or ask their doctor.

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